Sensitivity and Specificity of Serum and Salivary CYFRA21-1 in the Detection of Malignant Transformation in Oral Potentially Malignant Mucosal Lesions (Diagnostic Accuracy Study)
CYFRA21-1
1 other identifier
observational
24
1 country
1
Brief Summary
The study is designed to measure serum and salivary CYFRA21-1 levels using enzyme linked immunosorbent assay (ELISA) in patients with oral malignancy, oral potentially malignant lesions, and control subjects to evaluate the potential of CYFRA21-1 as a diagnostic marker for malignant transformation in potentially malignant oral mucosal lesions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2018
CompletedFirst Posted
Study publicly available on registry
September 26, 2018
CompletedStudy Start
First participant enrolled
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedJuly 23, 2019
July 1, 2019
11 months
September 24, 2018
July 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
sensitivity and specificity of serum and salivary CYFRA21-1 as a diagnostic marker in oral cancer
diagnostic accuracy in terms of sensitivity and specificity of serum and salivary CYFRA21-1 in differentiating between oral malignancy and oral potential malignant lesions in order to be able to early diagnose malignant changes in oral lesions.
one year
Study Arms (3)
Group I
participants suffering from oral potentially malignant lesions
Group II
participants suffering from diagnosed oral malignant lesions
Group III
healthy participants who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
Interventions
measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)
Eligibility Criteria
Egyptian population
You may qualify if:
- participants will be divided into 3 groups:
- Group I: patients suffering from oral potentially malignant lesions (PML) as defined by World Health Organization.
- Group II: patients suffering from diagnosed oral malignant lesions
- Group III: healthy subjects who are systemically free, non-smokers, and not suffering from any oral mucosal lesions.
You may not qualify if:
- Subjects taking any drugs inducing any changes that could affect the salivary flow.
- Pregnant females.
- Subjects have any allergies, infectious diseases or active dental abscesses during one month before saliva sampling.
- Patients receiving any drugs related to the oral lesions in the past 6 month prior to sample collection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (7)
Rajkumar K, Ramya R, Nandhini G, Rajashree P, Ramesh Kumar A, Nirmala Anandan S. Salivary and serum level of CYFRA 21-1 in oral precancer and oral squamous cell carcinoma. Oral Dis. 2015 Jan;21(1):90-6. doi: 10.1111/odi.12216. Epub 2013 Dec 30.
PMID: 24304502BACKGROUNDAlkotyfan K, Wiegand S, Muller HH, Windfuhr JP, Werner JA, Sesterhenn AM. Cyfra 21-1 as a tumor marker for follow-up of patients with squamous cell carcinoma of the oropharynx. Anticancer Res. 2010 Jun;30(6):2291-6.
PMID: 20651382BACKGROUNDAwasthi N. Role of salivary biomarkers in early detection of oral squamous cell carcinoma. Indian J Pathol Microbiol. 2017 Oct-Dec;60(4):464-468. doi: 10.4103/IJPM.IJPM_140_16.
PMID: 29323056BACKGROUNDGualtero DF, Suarez Castillo A. Biomarkers in saliva for the detection of oral squamous cell carcinoma and their potential use for early diagnosis: a systematic review. Acta Odontol Scand. 2016;74(3):170-7. doi: 10.3109/00016357.2015.1110249. Epub 2015 Nov 18.
PMID: 26577643BACKGROUNDMalhotra R, Urs AB, Chakravarti A, Kumar S, Gupta VK, Mahajan B. Correlation of Cyfra 21-1 levels in saliva and serum with CK19 mRNA expression in oral squamous cell carcinoma. Tumour Biol. 2016 Jul;37(7):9263-71. doi: 10.1007/s13277-016-4809-4. Epub 2016 Jan 15.
PMID: 26779624BACKGROUNDMortazavi H, Baharvand M, Mehdipour M. Oral potentially malignant disorders: an overview of more than 20 entities. J Dent Res Dent Clin Dent Prospects. 2014 Winter;8(1):6-14. doi: 10.5681/joddd.2014.002. Epub 2014 Mar 5.
PMID: 25024833BACKGROUNDWang YX, Hu D, Yan X. Diagnostic accuracy of Cyfra 21-1 for head and neck squamous cell carcinoma: a meta-analysis. Eur Rev Med Pharmacol Sci. 2013 Sep;17(17):2383-9.
PMID: 24065233BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PHD postgraduate student
Study Record Dates
First Submitted
September 24, 2018
First Posted
September 26, 2018
Study Start
October 23, 2018
Primary Completion
October 1, 2019
Study Completion
December 1, 2019
Last Updated
July 23, 2019
Record last verified: 2019-07